Karnataka - Apply for Drug License (Retail and Wholesale - Pharmacy)

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Procedure

• No individual can start or continue a business dealing drugs / cosmetics / medicine in India, unless an appropriate license is obtained from the designated authority.
• As different state has different parameters and regulations, as a first step applicant shall consult their local drug license authority to get advice on
  • Any updated rules and regulations in issuance of license.
  • Update on drugs that were included in the list for which license can’t be obtained.
  • Fees payment type etc.

Apply Online:

1. Please use the following link to apply online : link
2. In the given page use the login credentials and hit “Login” tab to login.
3. If you are a new user then use the “New Registration” button to reach the "Firm Application Registration:" page. Please complete the page prompts as appropriate and click the "Register" button. Please follow the onscreen instruction to complete the registration process.
4. The user name and password will be sent to the registered mobile number and email ID.
5. Please use them to login. In the given page, please click on the "Select Service" and choose the appropriate "Type of licenses and categories" from the options provided.
6. Once login, the applicant shall process the on screen information to get the online application form page.
7. Please complete the page prompts as appropriate with mandatory details including personal details, details of competent person, address details of premises, Uploading the required documents and completion of payment by uploading the required details.
8. Once all the mandatory details are filled, please use the applicable button to submit the application online. The system will provide the filled online application to confirm. Please process the page as appropriate to submit the application and get a system generated acknowledgement.
9. Please save it for future reference and get the printout of the application form.
10. Applicant gets notification about the submission of online application and different stages of process updates through "sms".
11. The application will be sent automatically to the respective department.
12. Once the acknowledgement and printout of online application in hand, please visit the respective drug inspector or the concerned authority with set of required documents. The authorities will verify the details. The authorities will provide the details about the rest of the process. The applicant shall follow the guidelines of the authorities.
13. Applicant gets notification about the process updates through "sms".
14. Once the applicant completes the other set of process as advised by the authorities by online or in person, the application will be processed further.
15. Drug inspector or the respective authority will inspect the premises for verifying the correctness.
16. On a scheduled date the inspection team/authority will inspect the premise.
17. After the inspection is over, Competent person will be asked to report for an interview.
18. Once the interview is complete and the above process are over, the controller of drugs or the appropriate authority will sanction the drug license.
19. If required, the applicant may be asked to pay the fees or charges as applicable.
20. The applicant will receive information about the issue of license.
21. The licence will hand delivered or can be download or delivered through mail or delivered as per applicable norms.

Note:

• Fee payment for the license is accepted in different formats like challan/cheque as applicable. Applicants are advised to take the consultation with the respective drug license authority for your area to prepare fees requirement.

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Required Documents

• The certificate of incorporation or registration
• MOA & AOA or Partnership deed / LLP agreement
• Pan card
• Aadhar card
• Age proof
• Cancelled cheque (for bank account detail requirement)
• List of directors
• ID and address proof of director
• Passport size photograph
• Board resolution on the letterhead
• Affidavit from directors
• Sale deed document of the premises
• If rented, registered rent agreement
• NOC from the owner
• Architect attested Key plan and site plan
• Fees paid details
• Document requirement from competent person
  • Bio data as per proforma
  • Appointment letter of competent person
  • Proof of qualification
  • Experience certificate
  • Passport size Photo
  • ID proof
  • Address proof
  • Affidavit of the competent person
    

Note :

• Please take above mentioned documents in original and attested copies thereof (to be submitted) at the time of applying.
• Please submit the applicable document from the above list as per applicant type.

Office Locations & Contacts

Drugs Control Department,
State of Karnataka,
P B No. 5377, Next to Carito House,
Palace Road,Bangalore-560001.
Phone: 080-22262846/ 22870943/ 23356134 (R)
Fax: 22286492 Email: [email protected]
Contact Link: link

Central Drugs Standard Control Organization Directorate General of Health Services
Ministry of Health and Family Welfare,
Government of India,
FDA Bhavan, ITO, Kotla Road, New Delhi -110002.
Phone:91-11-23216367(CDSCO)/ 23236975
Fax: 91-11-23236973
E-mail:[email protected]
Contact link: link

Eligibility

• Any person/company/partnership firm/LLP can apply for drug license
• A competent (registered pharmacist from the state pharmacy council) person with experience shall apply

Fees

Please use the following link for fees details. link

Validity

• Valid for period of 3 years
• The license should be prominently displayed at the place of business during the business hours.

Documents to Use

Please attach documents which can be used by people who would like to follow this procedure.    

Sample Documents

Please attach documents which can be used by people who would like to follow this procedure.    

Processing Time

45 days or as notified by the department

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type="website">video ID|width|height<&/video&> from external websites.
Please remove the "&" inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url "http://www.youtube.com/watch?v=Y0US7oR_t3M" Video ID is "Y0US7oR_t3M". 

Instructions

Please provide instructions on obtaining the certificate/documents.
e.g. The state office holds birth records since january 1908.

Required Information

A list which displays the kind of information which is required to complete the procedure.
e.g.
1. Date of Birth.
2. City or County of Birth.

Need for the Document

• A drug license is required to sell/distribute/store medicine. It can be obtained from appropriate government department.
• This license will be helpful to follow the rules and regulations set by regulatory department.

Information which might help

Government has laid down stringent law and regulations for manufacturing and distribution of drugs and medicines in India.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

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Others

More information which might help people.